FDA Device

Dynavox T10 Speech Generating Device ( including Batteries)

Hazard

The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.

What You Should Do

Remedy

On February 26, 2018 an URGENT MEDICAL RECALL LETTER was issued to customers with the subject line listing the serial number specific to that customer along with the date of purchase. The letter informs customers of the issue and instructs customers to return product to one of their facilities to have the product repaired until an RA. Questions or concerns can be directed to 1-800-344-1778, Press 1 and then Press 2.

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Products

Dynavox T10 Speech Generating Device ( including Batteries)
Brand
Dynavox Systems Llc
UPC
TS1308 TS1411  Part Numbers: T10: 750394  Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.

Units Affected

4615

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